Through the efforts of the GUDMAP consortium, substantial progress has been made in establishing a molecular
anatomy atlas of the developing murine kidney. This has provided a
significant resource in support of research in kidney development, repair and
regeneration. However, there remain significant gaps within the atlas in the
areas of the developing lower urinary tract (ureter, bladder, urethra,
sphincter, and prostate) and the developing vascular and nervous system
associated with the organs of the urinary tract.

To address these deficiencies, the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for
Cooperative Agreement Research Projects (U01) that focus on defining the
molecular anatomy of the developing murine lower urinary tract, or the
innervation and vasculature of the lower urinary tract organs. These
applications will be considered as part of a continuing GUDMAP effort.

Key Dates

Posted Date

January
27, 2011

Letter of Intent Due Date

March 10, 2011

Application Due Date(s)

April 7, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July, 2011

Advisory Council Review

October, 2011

Earliest Start Date(s)

December, 2011

Expiration Date

April 8, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide for Grants and Contracts). Conformance
to all requirements (both in the Application Guide and the FOA) is
required and strictly enforced. While some links are provided, applicants must
read and follow all application instructions in the Application Guide as well
as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The genitourinary (GU) tract encompasses organ systems and
structures commonly involved in congenital birth defects, and emerging data
suggest that the prevalence of some of these birth defects (e.g., hypospadias
and cryptorchidism) is increasing. Understanding the developmental basis for
these defects is only the first step in developing successful therapeutic
strategies to reduce or eliminate the defects.

There are important clinical implications to research on
early development. Abnormalities in embryonic development that result in birth
defects are likely to involve the disruption of many cellular signaling
cascades that would usually direct normal embryonic development. Many of the
same signaling networks become dysfunctional later in life and result in adult
disease. Furthermore, embryonic developmental factors are emerging as important
participants in adult regenerative and repair processes. Thus, a comprehensive
understanding of how organs develop in the embryo is necessary to effectively
interrogate maladaptive processes and understand regeneration. Successful development
of cell therapies to replace or repair damaged tissue will require knowledge of
the catalog of cell types for each organ; the genes that mark these cells, as
well as those that are required for their function; the regulatory factors that
induce or maintain the various cell types; and the developmental and anatomic
relationships of each cell type to its neighbor.

As a result, the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) and the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) sponsored the
GenitoUrinary (GU) Development Molecular Anatomy Project (GUDMAP) in 2002 to
(1) develop a low resolution gene expression atlas of all genes expressed
within the developing murine GU tract, (2) perform high resolution anatomic
gene expression studies using available or newly generated molecular tools, and
(3) produce an integrated, continuously updated database that provides the
entire research community with access to the data as it is generated.

Through the efforts of the GUDMAP consortium, substantial advances have been made in establishing a molecular
anatomy atlas of the developing murine kidney. Molecular markers have now been identified
for physiologically or anatomically defined cell types within the kidney and
for developmental established functional domains and helping to reveal the
genesis of kidney structure at the molecular and cellular level. This
fundamental description of the kidney provides a significant resource to
support research in kidney repair and regeneration, including stem cell
research, because the design of novel therapies relies on knowledge of the cell
types within an organ to determine whether putative therapies are effective at
regenerating them or restoring their functionality.

There are, however, considerable gaps within the atlas for
the other organs of the urinary tract, as well as for the vasculature and innervation
associated with urinary tract, including the kidney. There is a paucity of
cell-specific markers for key lineages, an incomplete understanding of the
normal innervation and vasculature of the major organs of the urinary tract,
and an absence of knowledge regarding the three dimensional cellular structure
of the major organs of the lower urinary tract (ureter, bladder, urethra,
sphincters, and prostate) and the morphogenetic events that occur during
organogenesis.

GUDMAP
Atlas Projects and the Ontology Team

This FOA invites applications for Atlas Projects and for the
Ontology Team that will work together as a consortium with the GUDMAP
Website/Database Center (RFA-DK-10-005).
The GUDMAP Website/Database Center will oversee the continued production of an
integrated, continuously updated database, and the incorporation of data
generated by the continuing GUDMAP Atlas Projects. The Ontology Team will
ensure that these data are accurately annotated and easily accessible to the entire
research community. Applicants should propose either an Atlas project or an
Ontology Team project in their application and indicate clearly which activity
is being proposed. Because these are distinct research activities,
investigators interested in both project types should submit two separate
applications. Combined applications for an Atlas Project and Ontology Team
will not be accepted.

GUDMAP
Atlas projects

GUDMAP Atlas projects will focus on defining the molecular
anatomy of the developing murine lower urinary tract. Projects studying the innervation
and vasculature of the major organs of the lower urinary tract may include the
kidney, however, projects that focus solely on the kidney will be considered unresponsive.
The goals of each of the applications for GUDMAP Atlas Projects are expected to
vary, depending upon the objectives they are designed to address; however,
projects must be focused on the organs of the lower urinary tract (e.g., ureter,
bladder, urethra, sphincters, prostate). Studies of the vasculature or
innervation may also include the kidney but cannot be solely focused on the
kidney. Examples of the types of projects that may be supported include, but
are not limited to:

Large scale spatial analyses of gene/protein expression utilizing
whole-mount in situ hybridization, or other in
situ approaches, or using libraries of antibodies. It is expected
that this type of approach will provide near-genome-wide analyses of gene
expression in the relevant organs and associated nervous or vascular systems at
a single time during development, expanding to a second time point if possible.

Low resolution analyses of gene expression through developmental
time, using high throughput strategies, but focusing on a restricted set of
genes. This approach may be suited to study the expression of a given class of
gene products, e.g., transmembrane proteins. This type of approach may be
especially suited for the urologic organs, for which studies examining gene
expression at multiple developmental stages are particularly lacking.

High resolution, three dimensional analyses of a set of genes or
gene products using, for example, tagged gene constructs, antibodies, or
section in situ hybridization. Various types of imaging may be useful, including confocal
microscopy, optical tomography, micro-MRI, or light microscopy. The goal is to
produce three dimensional representations of gene expression patterns and
relate them to functional, anatomical, or molecular hallmarks.

Analysis of gene expression programs in critical cell types using
state of the art technology (i.e., NexGen RNA sequencing, TRAP, etc) to
establish a set of novel cell type specific molecular markers. Labeled
cells/tissues may be generated via knock-ins, transgenic, or other methods.

It is expected that novel tools may need to be developed to
allow these studies to be conducted. This FOA will support GUDMAP Atlas projects for
the development of these tools, with the understanding that they will be
rapidly shared, prior to publication, with the general research community.

Ontology Team

It is expected that the successful application for
the Ontology Team will lead the development and monitoring of the ontology to
ensure the global integrity of all components of the urogenital tract, and to
ensure the utility of the GUDMAP website for all researchers working across all
urogenital tract organs. The Ontology Team will also facilitate and help
coordinate efforts with the GUDMAP Website/Database Center and GUDMAP Atlas
Projects to (a) improve the quality of the existing data within the GUDMAP
database and thereby enhance the utility of the GUDMAP website for the research
community, (b) extend the data content of the GUDMAP database by way of the
presentation of bioinformatics results from existing analyses, and (c) improve
the accessibility and utility of the GUDMAP website to end users.

It is expected that these studies will be very effective at
generating new hypotheses. For example, discovery of sequential activation of
gene expression in identical patterns might suggest a regulatory relationship
between the first and subsequent genes. Hypothesis generation is a goal of this
FOA. However, experiments to test these hypotheses are more suitable for investigator-initiated
R01 applications and are beyond the scope of this FOA. Such applications will
be considered non-responsive. Likewise, projects designed to test hypotheses
based on previously generated data are also unsuitable for this solicitation.

GUDMAP
Structure and Organization

The GUDMAP Atlas Projects and the Ontology Team will work
together with the GUDMAP Website/Database Center as a consortium. The GUDMAP
consortium is designed to serve as a resource to the research community, so all
of these components must be well integrated, coordinated, and materials freely
shared beyond the consortium members. All applicants for this FOA are expected
to indicate their willingness to participate as active members of the GUDMAP consortium
(see Cooperative Agreement Terms and Conditions of Award) and to work together
to establish database vocabularies, annotation criteria, and to provide
feedback regarding the utility of the GUDMAP database and the ease of use of
the GUDMAP website. Applicants are also expected to indicate their willingness
to distribute research tools to the wider community, including probe sets,
antibody libraries, transgenic or knock-in mouse strains, cell lines, and other
reagents, and to describe their willingness to submit data generated through
this project to the GUDMAP database prior to publications. It is expected that
data will be released to the database as soon as they are validated (see Special
Instructions for Appendix under Research Plan).

During the course of the funding period, technologies will
improve, and the rate of progress and focus of work supported by the
cooperative agreement might change. It is expected that the Principal
Investigator(s), in consultation with NIH program staff, the Steering
Committee, and the External Advisory Board will make any necessary adjustments
to accommodate the changing research environment, in order to remain focused on
overall consortium goals; to maintain excellent coordination with the other
projects; and to incorporate new technological advances.

Section
II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, scientific or program staff
will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit $1,000,000 in total cost to
support 2-3 atlas project awards and one ontology team award in FY2011.
Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited, but need to reflect
actual needs of the proposed project. The direct costs are expected to be in
the range of $100,000-$200,000 per year for a five-year period.

Award Project Period

Scope of the proposed project should determine the project
period. The maximum period is 5 years..

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations
described in the PHS398 Application Guide and the Table of
Page Limits must be followed.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Investigators who have generated GUDMAP data as part
of a subcontract may submit within the Progress Report within the Research
Strategy section. Please use the instructions provided for Progress Report for
Renewal/Revision Applications. Provide the beginning and ending dates for the
period covered. Summarize the specific aims of the previous project period and
the importance of the findings, and emphasize the progress made toward their
achievement.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398
Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Applicants are expected to include in the appendix a plan
addressing if, or how, they will exercise their intellectual property rights
while making available to the broader scientific community patentable research
resources, consistent with achieving the goals of this program. These plans
must be consistent with the applicant’s institution’s policies for intellectual
property.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide,

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be
reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Special requirements

Applicants must indicate their willingness to be part of a
GUDMAP consortium and be willing to participate in the Steering Committee for
this consortium, which will meet monthly through telephone conference calls,
semi-annually in person, and may meet additionally in subcommittees (see
Cooperative Agreement Terms and Conditions of Award). GUDMAP consortium
participants are expected to discuss progress toward each project, quality
assurance, and activities involved in coordination of projects, data and
reagent sharing, and means of informing the research community of progress (see
Cooperative Agreement Terms and Conditions of Award). The GUDMAP Atlas Project
participants are expected to work together and in coordination with the GUDMAP Ontology
Team and the GUDMAP Website/Database Center to establish database vocabularies
and annotation criteria and to provide feedback regarding ease of use and
database utility. This consortium is expected to serve as a resource to the
community, so the consortium members must maintain resource generation as the
primary objective for their participation in this consortium. Applicants must
indicate their willingness to distribute research tools to the wider community,
including probe sets, antibody libraries, transgenic or knock-in mouse strains,
cell lines, and other reagents, and describe their willingness to submit data
generated through this project to the GUDMAP database prior to publication. It
is expected that data will be released to the database as soon as they are
validated.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

In addition to standard review criteria, all applications will be judged on the
documented ability of the investigators to meet the RESEARCH OBJECTIVES of the
FOA.

It is expected that the proposed studies will be very
effective at generating hypotheses. Hypothesis generation is a goal of the
initiative, not hypothesis testing.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the atlas project or ontology team project to exert a sustained, powerful influence on the research
field(s) involved, in consideration of the following review criteria and
additional review criteria (as applicable for the project or team proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, an atlas project or ontology team project that by its nature is not innovative may be essential to
advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

For Atlas Project applications, do the genes chosen
for high resolution analysis mark distinct cell populations? Can the
expression of these genes be correlated to anatomic landmarks? Are the gene
sets chosen for high throughput studies well justified? Will the tools to be
generated be useful for the community?

For Ontology Team Project applications, does the application
describe significant leadership activities and strategies that will ensure
global integrity of the GUDMAP projects? Does the application propose valuable
modifications and improvements to the GUDMAP website/database in order to
improve accessibility and utility?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

For Atlas Project applications, do the PD/PIs and
other key personnel have a demonstrated track record of accomplishments
indicating that they are capable of carrying out the proposed work?

For Ontology Team Project applications, do the PD/PIs
have prior experience in the development and modification of ontology for
components of the urogenital tract?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project or team proposed, reviewers
will evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Interactions:

Are there adequate plans for effective interaction
and coordination among Consortium components and the NIH? Do the investigators
state their willingness to collaborate extensively and share information fully?
Do the investigators state their willingness to abide by the priorities and
policies agreed upon by the Steering Committee? Have the applicants proposed
sound strategies for communication within the GUDMAP consortium and with the
NIH?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of unusual
talent, resources, populations, or environmental conditions that exist in other
countries and either are not readily available in the United States or augment
existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIDDK (assignments will be shown in the eRA Commons), in accordance with NIH peer
review policy and procedures, using the stated review
criteria.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will compete for available funds with all other
recommended applications submitted in response to this FOA . Following initial
peer review, recommended applications will receive a second level of review by
the National Diabetes and Digestive and Kidney Diseases Advisory Council
(NDDKAC).. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Compliance with resource sharing policies and the evidence for
willingness to work cooperatively

Degree of originality and innovation;

Creativity of the approaches and technologies; and

Likelihood for substantial contribution by the applicants to a
successful collaborative effort

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole, although specific tasks and activities may
be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Defining the objectives and approaches, planning, conduct,
analysis, and publication of results, interpretations, and conclusions of
studies conducted under the terms and conditions of the cooperative agreement
award.

Accountability towards the applicant organization officials and
to the NIDDK for the performance and proper conduct of the research supported
by the project in accordance with the terms and conditions of the award.

Serving as a voting member of the Steering Committee and will
attend the Planning Meeting and a Steering Committee meeting in the first year,
two Steering Committee meetings a year in subsequent years and monthly
teleconference calls.

Accepting and implementing the goals, priorities, procedures,
protocols, and policies agreed upon by the Steering Committee and
subcommittees, and be responsible for close coordination and cooperation with
the components of the GUDMAP consortium and with NIH staff.

Adhering to PHS policy for the distribution of unique research
resources produced with PHS funding as described under Special Requirements.
The NIH Project Scientist, on behalf of the NIH, will have the same access,
privileges and responsibilities regarding the collaborative data as the other
members of the Steering Committee.

Establishing written milestones for the project, in negotiation
with NIDDK Project Staff within the first three months of the award period.

The PI is expected to put all study design materials and
procedure manuals into the public domain and/or make them available to other
investigators, according to the approved plan for making data and materials
available to the scientific community and the NIDDK, for the conduct of
research at no charge other than the costs of reproduction and distribution,
consistent with achieving the goals of this program initiative.

Add any additional bulleted information. Awardees will retain
custody of and have primary rights to the data and software developed under
these awards, subject to Government rights of access consistent with current DHHS,
PHS, and NIH policies.

NIH staff have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

An NIH Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below. However, the dominant role and prime responsibility for the
project as a whole resides with the awardees, although specific tasks and
activities in carrying out the studies will be shared by awardees and the
NIDDK.

NIDDK will designate a Project Officer and a Grants Management
Specialist to provide normal program stewardship and administrative oversight
of the cooperative agreement.

NIDDK will form an External Advisory Committee (EAC), comprised
of the NIDDK Project Scientist and other NIH extramural staff with relevant
scientific expertise or who manage research grant programs that relate
scientifically to the goals of the GUDMAP projects, and outside advisors
selected by the NIDDK. The EAC will meet annually with the GUDMAP Steering
Committee to review and assess the GUDMAP and to advise NIDDK Project Staff of
scientific developments and opportunities that may enhance the achievement of
the GUDMAP goals.

The NIDDK Project Scientist will attend and participate as a
voting member in all meetings of the Steering Committee, and provide liaison
between the Steering Committee and the External Advisory Committee.

The NIDDK Project Scientist will help the Steering Committee
develop and draft operating policies.

The NIDDK Project Officer will review the scientific progress of
the GUDMAP database/website, access for compliance with operating policies
developed by the Steering Committee, and may recommend to the NIDDK to withhold
support, suspend, or terminate an award for lack of scientific progress or
failure to adhere to policies established by the Steering Committee.

An agency program official or IC program director will be
responsible for the normal scientific and programmatic stewardship of the award
and will be named in the award notice. The assigned Program Officer may also
serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Steering Committee - The NIH Project Scientist, PIs from the
project funded through this FOA and RFA-DK-10-005,
and voluntary representatives from the previously funded GUDMAP atlas projects
funded under PAR-04-042 will be responsible for forming a Steering Committee as defined below. An
arbitration system, as detailed below, will be available to resolve
disagreements among members of the Steering Committee. The Steering Committee
will be the main governing board of the GUDMAP consortium. It will develop
collaborative protocols, identify technological impediments to success and
strategies to overcome them, develop shared software tools for disseminating
information about the projects, and identify opportunities for sharing
techniques and tools that might be developed in future GUDMAP atlas projects.

The Steering Committee will be composed of the PIs from the
project funded through this FOA and RFA-DK-10-005,
representatives from the previously funded GUDMAP projects, and the NIDDK
Project Scientist. The representatives and the PIs will each have one vote. The
NIDDK Project Scientist for this project will have one vote. The Steering Committee
will select a chairperson who will be someone other than an NIH staff member.

The Steering Committee may, as it deems necessary, invite
additional, non-voting scientific advisors to meetings at which research
priorities and opportunities are discussed. The NIH reserves the right to
augment the scientific or consumer expertise of the Steering Committee when
necessary.

There will be two Steering Committee meetings annually, both in
the Washington, DC area. The first meeting will be a Planning Meeting on October 13-14, 2011.
At the Planning Meeting, the Steering Committee will be formed and a
chairperson selected from among the members. At the Planning Meeting, the
Steering Committee may: (a) draft a charter to detail policies and procedures,
a process for monitoring compliance with the policies and procedures, and a
process for recommending that the NIH Project Administrators act on evidence of
non-compliance of any Consortium component with Steering Committee policies;
(b) agree upon the terms of the charter; and (c) devise a plan for working with
the GUDMAP database developers to provide ongoing input into database and
website design.

At the second and subsequent meetings, the Steering Committee
will refine the GUDMAP scientific objectives and implementation as necessary,
consistent with data produced by former and possible future GUDMAP atlas
projects and from other laboratories.

The Steering Committee will plan workshops, to which non-GUDMAP
participants will also be invited, to inform the research community of the
progress made toward development of the atlas, and to inform the research
community of any technological advances related to the implementation of the
GUDMAP website/database. The NIDDK Project Scientist, the External Advisory
Committee, and other NIH staff as appropriate will provide the Steering
Committee with advice on participants for the workshops and symposia.

The Steering Committee may establish subcommittees as it deems
appropriate; the NIH Project Scientist on subcommittees as they deem
appropriate.

Each full member will have one vote. Awardee members of the
Steering Committee will be required to accept and implement policies approved
by the Steering Committee.

The EAC will meet annually with the GUDMAP Steering Committee to
review and assess the progress of the GUDMAP consortium and to advise NIDDK
Project Staff of scientific developments and opportunities that may enhance the
achievement of the GUDMAP goals.

Dispute Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and Financial Status Report are required when an award is
relinquished when a recipient changes institutions or when an award is
terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.